Journal Article

Sertraline Treatment of Children and Adolescents With Posttraumatic Stress Disorder: A Double-Blind, Placebo-Controlled Trial

Sporn, Jonathan, Robb, Adelaide S., Vanderburg, Douglas G., Yang, Ruoyong, Cueva, Jeanette E.

2010

Overview

Objective: The aim of this study was to evaluate the safety and efficacy of sertraline in children and adolescents who met Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for posttraumatic stress disorder (PTSD). Method: Children and adolescents (6–17 years old) meeting DSM-IV criteria for PTSD were randomized to 10 weeks of double-blind treatment with sertraline (50–200 mg/day) or placebo. The primary efficacy measure was the University of California, Los Angeles Post-Traumatic Stress Disorder Index for DSM-IV (UCLA PTSD-I). Results: A total of 131 patients met entry criteria and were randomized to sertraline (n = 67; female, 59.7%; mean age, 10.8; mean UCLA PTSD-I score, 43.8 ± 8.5) or placebo (n = 62; female, 61.3%; mean age, 11.2; mean UCLA PTSD-I score, 42.1 ± 8.8). There was no difference between sertraline and placebo in least squares (LS) mean change in the UCLA PTSD-I score, either on a completer analysis (−20.4 ± 2.1 vs. −22.8 ± 2.1; p = 0.373) or on an last observation carried forward (LOCF) end point analysis (−17.7 ± 1.9 vs. −20.8 ± 2.1; p = 0.201). Attrition was higher on sertraline (29.9%) compared to placebo (17.7%). Discontinuation due to adverse events occurred in a 7.5% treated with sertraline and 3.2% treated with placebo. Conclusions: Sertraline was a generally safe treatment in children and adolescents with PTSD, but did not demonstrate efficacy when compared to placebo during 10 weeks of treatment. ClinicalTrials.gov Identifier: NCT00150306.

• Publisher: SAGE Publications,Mary Ann Liebert, Inc
• Subject: Adolescent / Antidepressants / Child / Child & adolescent psychiatry / Clinical outcomes / Clinical psychology / Clinical trials / Demographic aspects / Diagnostic and Statistical Manual of Mental Disorders / Dosage and administration / Dose-Response Relationship, Drug / Double-Blind Method / Drug therapy / Female / Humans / Male / Post traumatic stress disorder / Psychopharmacology / Serotonin Uptake Inhibitors - administration & dosage / Serotonin Uptake Inhibitors - adverse effects / Serotonin Uptake Inhibitors - therapeutic use / Sertraline / Sertraline - administration & dosage / Sertraline - adverse effects / Sertraline - therapeutic use / Stress Disorders, Post-Traumatic - drug therapy / Stress Disorders, Post-Traumatic - physiopathology / Treatment Outcome